Module 5 Presentations

16/07/2024

THE CONTINUING EVALUATION OF SAFETY

Clinical development progresses after demonstration of adequate safety in previous clinical trials and additional non-clinical safety information

‘Post marketing’

Clinical or non-clinical findings may influence: • re-evaluation of previous clinical adverse events

Regulatory Approval

Volunteer Patients

• continuation of clinical trials • additional non-clinical studies • extra clinical investigations

Healthy volunteers

Provide reassurance & build confidence to proceed ...........

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

11

Quantifying the Risks - THERAPEUTIC INDEX

Unwanted pharmacology Secondary pharmacodynamics Adverse effects Toxicity

Intended pharmacology Primary pharmacodynamics

Patrick Y. Muller and Mark N. Milton (novartis) - Nature Reviews, Drug Discovery – 2012

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

12

6